CClinicalTrials.gg
RecruitingNCT06889987Updated Mar 21, 2025

Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block Versus Bilateral Lateral Quadratus Lumborum Plane Block in Controlling Postoperative Pain in Cancer Patients Undergoing Open Nephrectomy

An interventional study of Intramuscular quadratus lumborum block and Lateral quadratus lumborum block in Bilateral, Ultrasound and Intramuscular Quadratus Lumborum Plane Block, sponsored by National Cancer Institute, Egypt. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Dec 2024, registered Mar 2025).
  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy.

Read the detailed description

Post-surgical somatic pain is very distressing to patients, which may lead to significant complications.

Practitioners initially used these as ilioinguinal, iliohypogastric, rectus sheath blocks, and in the early 21st century, transversus abdominis plane (TAP) blocks. A recent variation of the TAP block is known as the quadratus lumborum block (QLB).

The QL block effectiveness is believed to result from the spread of Local Anesthetic cranially from the lumbar deposition into the thoracic paravertebral space (TPVS). So, the QLB seems to relieve somatic and visceral pains.

02

Conditions studied

  • Bilateral
  • Ultrasound
  • Intramuscular Quadratus Lumborum Plane Block
  • Lateral Quadratus Lumborum Plane Block
  • Postoperative Pain
  • Cancer Patients
  • Open Nephrectomy

Browse trials for

03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status II-III.
  • Body mass index (BMI): (20- 40) kg/m2.
  • Type of surgery: midline incision for unilateral open nephrectomy.

Exclusion criteria

Exclusion Criteria:

  • Patient refusal.
  • Age \<18 years or >65 years
  • BMI \<20 kg/m2 and > 40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia, e.g. local infection at the introduction site, pre-existing peripheral neuropathies and coagulopathy.
  • Physical status ASA IV
  • Patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • Patients with a history of drug abuse
  • Patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
  • All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Intramuscular quadratus lumborum group

    Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia.

    Drug: Intramuscular quadratus lumborum block

  • Experimental
    Lateral quadratus lumborum group

    Patients will receive bilateral Ultrasound-guided lateral quadratus lumborum with injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia.

    Drug: Lateral quadratus lumborum block

  • Active comparator
    Control group

    Patients will receive only general anesthesia without any block

    Drug: General anesthesia

Interventions

  • DrugIntramuscular quadratus lumborum block

    Patients will receive bilateral ultrasound-guided intramuscular quadratus lumborum block with an injection of 0.4 ml/kg bupivacaine 0.25% after induction of general anesthesia

    Also known as: Bupivacaine 0.25%

  • DrugLateral quadratus lumborum block

    Patients will receive bilateral ultrasound-guided lateral quadratus lumborum with an injection of 0.4 ml/kg of bupivacaine 0.25 after induction of general anesthesia.

    Also known as: Bupivacaine 0.25%

  • DrugGeneral anesthesia

    Patients will receive only general anesthesia without any block.

06

What researchers measure

Primary outcomes

  1. Degree of pain

    The degree of pain will be assessed using the Visual Analogue Scale (VAS) where 0 (no pain) and 10 (the worst pain). VAS score in each technique at 0, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Total amount of morphine consumption

    Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Visual Analogue Scale (VAS) ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

    Time frame: 24 hours postoperatively

  2. Total amount of fentanyl consumption

    Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

    Time frame: Intraoperatively

  3. Change in heart rate

    Change in heart rate will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  4. Change in mean arterial blood pressure

    Change in mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals and record the average of each three successive readings, then at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

    Time frame: 24 hours postoperatively

  5. Incidence of postoperative nausea and vomiting

    Incidence of postoperative nausea and vomiting will be recorded.

    Time frame: 24 hours postoperatively

  6. Time of first rescue analgesia

    Time of first rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

    Time frame: 24 hours postoperatively

  7. Incidence of complications related to block

    Incidence of complications related to block such as local anesthetic systemic toxicity and arterial puncture will be recorded.

    Time frame: 24 hours postoperatively

  8. Incidence of morphine related complications

    Incidence of morphine-related complications such as respiratory depression, urine retention or pruritis will be recorded.

    Time frame: 24 hours postoperatively

  9. Degree of patient satisfaction

    The patient will be classified in this group to be satisfied or not.

    Time frame: 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • National Cancer Institute
    Cairo, 11796, Egypt
    • Ahmed M Salama, Master · Contact · dr.Ahmed.ismail93@gmail.com · 00201024275085
    • Mohamed A El-Ramli, MD · Sub investigator
    • Ahmed S Ragab, MD · Sub investigator
    • Noha M Abd El-Monem, MD · Sub investigator
    • Osama M El-Bosraty, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889987
Lead sponsor
National Cancer Institute, Egypt
Responsible party
Ahmed Ismail (Assistant Lecturer of Anesthesia, Pain Relief, and Intensive Care Unit, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt., National Cancer Institute, Egypt) — Principal investigator
First posted
Mar 21, 2025
Start date
Dec 10, 2024
Primary completion
Dec 6, 2025 (estimated)
Completion
Dec 6, 2025 (estimated)
Last update
Mar 21, 2025

Study contacts

Ahmed M Salama, Master
Contact
dr.Ahmed.ismail93@gmail.com
00201024275085

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion